- Zhongshan Mei Tung Electronics Ltd.
- Issuing Office:
- Center for Devices and Radiological Health
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||10903 New Hampshire Avenue|
White Oak Building 66
Silver Spring, MD 20993
OCT 23, 2014
VIA UNITED PARCEL SERVICE
Senior Manager – Quality
Zhongshan Mei Tung Electronics Ltd.
Shenglong Industrial Park, Muhejing Industrial Zone
Dear Mr. Poon:
During an inspection of your firm located in Zhongshan, China, on June 23, 2014, through June 25, 2014, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures digital thermometers, nasal aspirators, liquid medication dispensers, and manual toothbrushes. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or function of the body.
This inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. FDA received responses from you dated July 3, 2014, and August 5, 2014, concerning the investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, which was issued to your firm. Your firm’s response, dated August 5, 2014, to the Form FDA 483 (FDA 483) was not reviewed because it was not received within fifteen business days of issuance of the FDA 483. This response will be evaluated along with any other written material provided in response to the violations cited in this Warning Letter. These violations include, but are not limited to, the following:
1. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198. For example, your firm's procedure for customer complaint handling, [(b)(4)], Edition A, dated October 15, 2009, fails to:
a. Contain provisions for evaluating customer complaints for medical device reportability;
b. Ensure that all complaints are reviewed and evaluated to determine whether an investigation is necessary;
c. Ensure that all complaints are processed in a uniform and timely manner.
We reviewed your firm’s response and conclude that it is not adequate. Your firm states that it plans to revise the operation procedure, (b)(4) Customer Complaint Procedure. However, your firm’s response does not include the updated procedure for our review or state plans to provide training on the new procedure. Furthermore, your firm did not perform, nor does it indicate plans to perform, a retrospective review to ensure that previous complaints were adequately addressed.
2. Failure to establish and maintain procedures for implementing corrective and preventive action (CAPA), as required by 21 CFR 820.100(a). For example, your firm's corrective and preventive action procedure, (b)(4) Edition A, dated October 15, 2009, fails to:
a. Include requirements for analyzing sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems;
b. Employ appropriate statistical methodology necessary to detect recurring quality problems;
c. Include requirements for verifying or validating the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished device.
We reviewed your firm’s response and conclude that it is not adequate. In response to the observation, your firm plans to revise its operation procedure, (b)(4), Corrective and Preventive Action Procedure. However, your firm’s response does not include the updated procedure for our review or indicate plans for providing training on the new procedure. Furthermore, your firm did not perform, nor does it indicate plans to perform, a retrospective review to ensure that previous CAPAs were adequately addressed.
3. Failure to establish and maintain procedures for acceptance of incoming product, as required by 21 CFR 820.80(b). For example, your firm did not inspect and document the incoming digital thermometers in accordance with its sampling plan. Your firm's sampling plan is based on (b)(4) an (b)(4) major defects and (b)(4) for minor defects. Specifically:
a. On or around June 5, 2014, your firm received a shipment of (b)(4) from its supplier. Your firm's inspection sheet showed a required sample size (b)(4). However, your firm only inspected and documented (b)(4).
b. On or around May 16, 2014, your firm received a shipment of (b)(4) from its supplier. Your firm's inspection sheet showed a required sample size (b)(4). However, your firm only inspected and documented (b)(4).
We reviewed your firm’s response and conclude that it is not adequate. In response to the observation, your firm plans to revise its sampling plan instructions to ensure that all incoming digital thermometers are inspected using (b)(4). However, your firm’s response does not include the updated procedure for our review or indicate plans to provide training on the new procedure. Furthermore, your firm did not perform, nor does it indicate plans to perform, any evaluation or assessment to confirm whether released devices conform to specifications.
4. Failure to establish and maintain acceptance procedures, where appropriate, to ensure that specified requirements for (b)(4) product are met, as required by 21 CFR 820.80(c). For example, your firm's instructions for (b)(4) thermometer testing, (b)(4), dated April 24, 2011, require checking the temperature readings at ambient condition and again in a heated-air surrounding to verify the temperature variation. Your firm failed to provide documentation as to whether the required test was conducted.
We reviewed your firm’s response and conclude that it is not adequate. In response to the observation, your firm plans to add a testing record for the thermometers after (b)(4) testing. However, your firm does not include the updated procedure for our review or indicate plans to provide training on the new procedure. Furthermore, your firm did not perform, nor does it indicate plans to perform, any evaluation or assessment to confirm whether released devices conform to specifications.
This inspection also revealed that your firm’s devices are misbranded under Section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed or refused to furnish material or information regarding the devices that is required by or under Section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 803 - Medical Device Reporting (MDR). Significant deviations include, but are not limited to:
5. Failure to develop, maintain, and implement written MDR procedures as required by 21 CFR 803.17. For example, during the inspection, your firm acknowledged that it does not have an MDR procedure.
We reviewed your firm’s response and conclude that it is not adequate. Your firm developed a procedure titled, “(b)(4) Medical Device Reporting Procedure,” Edition A, dated July 1, 2014. After reviewing that procedure, the following issues were noted:
a. (b)(4), Edition A, does not establish internal systems that provide for timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements. For example: the procedure omits the definitions of the terms “become aware,” “caused or contributed,” and “malfunction,” and the definition of the term “reasonably suggests,” found in 21 CFR 803.20(c)(1). The exclusion of these definitions from the procedure may lead your firm to make an incorrect reportability decision when evaluating a complaint that may meet the criteria for reporting under 21 CFR 803.50(a).
b. (b)(4), Edition A, does not establish internal systems that provide for timely transmission of complete medical device reports. Specifically, the following is not addressed: The procedure does not include the address for where to submit MDR reports: FDA, CDRH, Medical Device Reporting, P.O. Box 3002, Rockville, MD 20847-3002.
c. (b)(4), Edition A, does not describe how your firm will address documentation and record-keeping requirements, including:
i. Documentation of adverse event related information maintained as MDR event files;
ii. Information that was evaluated to determine if an event was reportable;
iii. Documentation of the deliberations and decision-making processes used to determine if a device-related death, serious injury, or malfunction was or was not reportable;
iv. Systems that ensure access to information that facilitates timely follow-up and inspection by FDA.
The eMDR Final Rule requiring manufacturers and importers to submit electronic MDRs to
FDA was published on February 13, 2014. The requirements of this final rule will take effect on August 14, 2015. If your firm is not currently submitting reports electronically, we encourage you to visit the following web link for additional information about the electronic reporting requirements: http://www.fda.gov/ForIndustry/FDAeSubmitter/ucm107903.htm
If your firm wishes to discuss MDR reportability criteria or to schedule further communications, it may contact the Reportability Review Team by email at ReportabilityReviewTeam@fda.hhs.gov.
Given the serious nature of the violations of the Act, digital thermometers, nasal aspirators, liquid medication dispensers, and manual toothbrushes manufactured by your firm are subject to refusal of admission under section 801(a) of the Act, 21 U.S.C. § 381(a), in that they appear to be adulterated. As a result, FDA is taking steps to refuse entry of these devices into the United States, known as “detention without physical examination,” until these violations are corrected. In order to remove the devices from detention, your firm should provide a written response to this Warning Letter as described below and correct the violations described in this letter.
Also, U.S. federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the award of contracts. Additionally, premarket approval applications for Class III devices to which the Quality System regulation deviations are reasonably related will not be approved until the violations have been corrected.
Please notify this office in writing within fifteen business days from the date your firm receives this letter of the specific steps taken to correct the noted violations, including an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Please include documentation of the corrections and/or corrective action (which must address systemic problems) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Please provide a translation of documentation not in English to facilitate our review. FDA will notify your firm regarding the adequacy of your firm’s responses and the need to re-inspect your firm’s facility to verify that the appropriate corrections and/or corrective actions have been made.
Your firm’s response is to be sent to: Food and Drug Administration, Center for Devices and Radiological Health, Office of Compliance, Field Inspections Support Branch, White Oak Building 66, Rm 2622, 10903 New Hampshire Ave., Silver Spring, MD 20993. Refer to CMS case #435114 when replying. For questions about the contents of this letter, please contact: Daniel Walter, Chief, Foreign Enforcement Branch, via telephone and/or facsimile, at +1(301)796-5587 or +1(301)847-8137, respectively.
Finally, this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of the violations and take prompt actions to correct them and bring your firm’s products into compliance.
Steven D. Silverman
Office of Compliance
Center for Devices and Radiological Health
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